BEUDAMED
    FDA Adverse Event Other Summary report: N

    DCATHLON GOLD

    MDR report key: 1508121 · Received October 2, 2009

    Report

    Report Number
    1223643-2009-00002
    Event Type
    Other
    Date Received
    October 2, 2009
    Date of Event
    August 29, 2009
    Report Date
    September 30, 2009
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    PMA / PMN Number
    K063431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: THE RESULTS OF THE ABOVE INVESTIGATION SHOW THAT THE INADEQUATE TUBING PENETRATION IS CAUSED BY THE TUBING BEING PUSHED DOWN DURING THE MOLDING PROCESS. THIS TUBING MOVEMENT, WHICH OCCURS ONLY ON RARE OCCASIONS, IS CAUSE BY PRESSURE OF THE FLOW FROM ONE OF THE TWO GATES IN THE MOLD. A SECOND (DISTAL) GATE WAS ADDED IMMEDIATELY BEFORE PRODUCTION OF THE MOLDING LOT FROM WHICH THE FIELD FAILURE SAMPLES WERE PRODUCED. THIS GATE IS POSITIONED APPROXIMATELY AT THE DEPTH TO WHICH THE TUBING IS INSERTED IN THE MOLD. WE ALSO HYPOTHESIZE THAT TUBING ON THE LOW END OF THE DIAMETRICAL SPECIFICATION RANGE MAY CONTRIBUTE TO MOVEMENT, AND CONSEQUENTLY LOW ENGAGEMENT DEPTH. THE INVESTIGATIONS ALSO REVEALED EVIDENCE OF SPORADIC "COLD MOLD" CONDITIONS, WHERE THE OVERMOLDED HUB MATERIAL WAS NOT FULLY BONDED TO THE TUBING. CONCLUSIONS: THREE FIELD FAILURES HAVE BEEN REPORTED FROM A SINGLE FINISHED GOODS LOT. THE OBSERVED FIELD FAILURES LIKELY RESULTED FROM A COMBINATION OF LIMITED ENGAGEMENT DEPTH OF THE TUBING INTO THE MOLDED HUB AND INADEQUATE FUSION DUE TO "COLD MOLD" CONDITIONS. THE COMBINATION OF THESE TWO EVENTS OCCURS ONLY VERY RARELY. THE MOST LIKELY CLINICAL COMPLICATION IS BLEEDING, WHICH IS READILY OBSERVABLE TO THE PATIENT AND MEDICAL PERSONNEL. SPIRE IS IN THE PROCESS OF DETERMINING AND IMPLEMENTING APPROPRIATE CORRECTIVE ACTIONS TO LIMIT FUTURE OCCURRENCE OF THIS PROBLEM. IN THE MEANTIME, A NON-DESTRUCTIVE TEST IS BEING DEVELOPED TO DETERMINE ENGAGEMENT DEPTH. THIS TEST WILL BE USED FOR 100% INSPECTION OF CURRENT AND FUTURE INVENTORY UNTIL THE CORRECTIVE ACTIONS ARE IMPLEMENTED.

    Description of Event or Problem · 1

    CUSTOMER SERVICE RECEIVED A CALL FROM AN AUTHORIZED DISTRIBUTOR. A (B)(4) CATHETER WAS IMPLANTED IN A PATIENT ON (B)(6) 2009, AND REPLACED WITH ANOTHER (B)(4) ON (B)(6) 2009. THE PATIENT WENT FOR A DIALYSIS TREATMENT AND WAS BLEEDING. THE CATHETER LUMEN WAS PARTIALLY ATTACHED AT THE HUB. THERE WAS NO INJURY TO THE PATIENT, AND A NEW CATHETER WAS PLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCATHLON GOLD MSD (LONG TERM HEMODIALYSIS CATHETER) MSD SPIRE BIOMEDICAL, INC. DFC19SH24-K 99608316-1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention